FDA Reverses Decision, Will Review Moderna's mRNA Flu Vaccine
The FDA has agreed to review Moderna's mRNA flu vaccine after initially rejecting it, with a decision expected by August 2026. The reversal occurs amid a contraction in the vaccine sector, with funding drops and layoffs under the Trump administration.
The Food and Drug Administration has reversed its previous decision and agreed to review Moderna's mRNA-based flu vaccine. Moderna said the agency will now accept its application, setting an August 2026 deadline for a decision.
Moderna is seeking traditional approval for people aged 50 to 64 and accelerated approval for those 65 and older. The company also agreed to conduct an additional study among those 65 and older once the vaccine reached the market.
The FDA had initially rejected the application, citing concerns over the control vaccine used in the company's study, but the two sides have since held further discussions. The reversal comes amid broader turmoil in the U.S. vaccine sector under Health Secretary Robert F. Kennedy Jr., who has repeatedly criticized mRNA vaccines as unsafe and ineffective.
Moderna has paused its influenza and Epstein-Barr projects, and the company has laid off over 800 employees, roughly one-tenth of its workforce. Other biotech firms have also scaled back: NTx Bio in Texas canceled plans for a facility that would have created more than 170 jobs, and Vaxcyte and TriLink BioTechnologies reported cuts or suspensions in new product development.
Funding for mRNA vaccine startups dropped to $174 million last year, down from $510 million in 2023. Blackstone had invested $750 million in Moderna's flu vaccine program, an investment now at risk.
In an earnings call, Moderna's CEO stated, "The current uncertainty in the U.S. F.D.A. regulatory environment creates real challenges for businesses, patients and the broader innovation ecosystem." The FDA commissioner, speaking at an industry event, remarked, "I want to see more kids get vaccinated," signaling ongoing support for immunization despite the fraught climate.
The FDA is set to decide on the flu vaccine by August 2026, which could make it available for older adults in the upcoming flu season. Preschool vaccination rates have been declining, and demand for flu shots has hit its lowest level in more than a decade. The national childhood immunization schedule was revised, reducing the recommended number of doses from 17 to 11. Moderna's president warned that "there will be less invention, investment, and innovations in vaccines generally, across all the companies."